Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment

Sponsor
University Hospital Tuebingen
Study ID
NCT02965443
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg + Saxagliptin 5 mg — DRUG
    24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg
  • Placebo 1 10 mg + Placebo 2 5 mg — DRUG
    24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg

Study Details

To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.

Key Dates

Start date
Feb 2, 2018
Status verified
May 2018
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Verum
    Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks
  • Placebo Comparator: Placebo
    Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks

Primary Outcome Measure

Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen [ Time Frame: 24 weeks ]

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